Cloprostenol Formulation

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SECTION 1. IDENTIFICATION

Product name : Cloprostenol Formulation Manufacturer or supplier's details

Company name of supplier : Merck & Co., Inc

Address : 2000 Galloping Hill Road

Kenilworth - New Jersey - U.S.A. 07033

Telephone : 908-740-4000

Telefax : 908-735-1496

Emergency telephone : 1-908-423-6000

E-mail address : [email protected]

Recommended use of the chemical and restrictions on use Recommended use : Veterinary product

SECTION 2. HAZARDS IDENTIFICATION

GHS classification in accordance with 29 CFR 1910.1200 Not a hazardous substance or mixture.

GHS label elements

Not a hazardous substance or mixture.

Other hazards None known.

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance / Mixture : Mixture

Components

Chemical name CAS-No. Concentration (% w/w)

Sodium [1α(Z),2β(1E,3R*),3α,5α]-(+/- )-7-[2-[4-(3-chlorophenoxy)-3-

hydroxybut-1-enyl]-3,5-

dihydroxycyclopentyl]hept-5-enoate

55028-72-3 < 0.1

Actual concentration is withheld as a trade secret

SECTION 4. FIRST AID MEASURES

If inhaled : If inhaled, remove to fresh air.

Get medical attention if symptoms occur.

In case of skin contact : Wash with water and soap as a precaution.

In case of eye contact : Flush eyes with water as a precaution.

Get medical attention if irritation develops and persists.

If swallowed : If swallowed, DO NOT induce vomiting.

Rinse mouth thoroughly with water.

Most important symptoms and effects, both acute and delayed

: None known.

Protection of first-aiders : No special precautions are necessary for first aid responders.

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Notes to physician : Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES

Suitable extinguishing media : Water spray

Alcohol-resistant foam Carbon dioxide (CO2) Dry chemical

Unsuitable extinguishing media

: None known.

Specific hazards during fire fighting

: Exposure to combustion products may be a hazard to health.

Hazardous combustion products

: No hazardous combustion products are known

Specific extinguishing methods

: Use extinguishing measures that are appropriate to local cir- cumstances and the surrounding environment.

Use water spray to cool unopened containers.

Remove undamaged containers from fire area if it is safe to do so.

Evacuate area.

Special protective equipment for fire-fighters

: Wear self-contained breathing apparatus for firefighting if necessary.

Use personal protective equipment.

SECTION 6. ACCIDENTAL RELEASE MEASURES Personal precautions, protec-

tive equipment and emergency procedures

: Follow safe handling advice and personal protective equipment recommendations.

Environmental precautions : Discharge into the environment must be avoided.

Prevent further leakage or spillage if safe to do so.

Prevent spreading over a wide area (e.g., by containment or oil barriers).

Retain and dispose of contaminated wash water.

Local authorities should be advised if significant spillages cannot be contained.

Methods and materials for containment and cleaning up

: Soak up with inert absorbent material.

For large spills, provide diking or other appropriate

containment to keep material from spreading. If diked material can be pumped, store recovered material in appropriate container.

Clean up remaining materials from spill with suitable absorbent.

Local or national regulations may apply to releases and disposal of this material, as well as those materials and items employed in the cleanup of releases. You will need to

determine which regulations are applicable.

Sections 13 and 15 of this SDS provide information regarding certain local or national requirements.

SECTION 7. HANDLING AND STORAGE

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Technical measures : See Engineering measures under EXPOSURE CONTROLS/PERSONAL PROTECTION section.

Local/Total ventilation : Use only with adequate ventilation.

Advice on safe handling : Handle in accordance with good industrial hygiene and safety practice, based on the results of the workplace exposure assessment

Take care to prevent spills, waste and minimize release to the environment.

Conditions for safe storage : Keep in properly labeled containers.

Store in accordance with the particular national regulations.

Materials to avoid : Do not store with the following product types:

Strong oxidizing agents

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Ingredients with workplace control parameters

Components CAS-No. Value type

(Form of exposure)

Control parameters / Permissible concentration

Basis

Sodium

[1α(Z),2β(1E,3R*),3α,5α]-(+/-)- 7-[2-[4-(3-chlorophenoxy)-3- hydroxybut-1-enyl]-3,5- dihydroxycyclopentyl]hept-5- enoate

55028-72-3 TWA 0.01 µg/m³ Internal

Wipe limit 0.1 µg/100 cm2 Internal 5 (OEB) Internal

Engineering measures : Use closed processing systems or containment technologies to control at source (e.g., glove boxes/isolators) and to prevent leakage of compounds into the workplace.

All engineering controls should be implemented by facility design and operated in accordance with GMP principles to protect products, workers, and the environment.

No open handling permitted.

Totally enclosed processes and materials transport systems are required.

Operations require the use of appropriate containment technology designed to prevent leakage of compounds into the workplace.

Personal protective equipment

Respiratory protection : No personal respiratory protective equipment normally required.

Hand protection

Material : Chemical-resistant gloves

Remarks : Consider double gloving.

Eye protection : Wear safety glasses with side shields or goggles.

If the work environment or activity involves dusty conditions, mists or aerosols, wear the appropriate goggles.

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Wear a faceshield or other full face protection if there is a potential for direct contact to the face with dusts, mists, or aerosols.

Skin and body protection : Work uniform or laboratory coat.

Additional body garments should be used based upon the task being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.

Use appropriate degowning techniques to remove potentially contaminated clothing.

Hygiene measures : Ensure that eye flushing systems and safety showers are located close to the working place.

When using do not eat, drink or smoke.

Wash contaminated clothing before re-use.

The effective operation of a facility should include review of engineering controls, proper personal protective equipment, appropriate degowning and decontamination procedures, industrial hygiene monitoring, medical surveillance and the use of administrative controls.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

Appearance : Aqueous solution

Color : clear

Odor : No information available.

Odor Threshold : No data available

pH : No data available

Melting point/freezing point : No data available Initial boiling point and boiling

range

: No data available Flash point : No data available Evaporation rate : No data available Flammability (solid, gas) : Not applicable Flammability (liquids) : No data available Upper explosion limit / Upper

flammability limit

: No data available

Lower explosion limit / Lower flammability limit

: No data available

Vapor pressure : No data available Relative vapor density : No data available

Relative density : 1

Density : No data available

Solubility(ies)

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Water solubility : soluble Partition coefficient: n-

octanol/water

: Not applicable Autoignition temperature : No data available Decomposition temperature : No data available Viscosity

Viscosity, kinematic : No data available Explosive properties : Not explosive

Oxidizing properties : The substance or mixture is not classified as oxidizing.

Particle size : Not applicable

SECTION 10. STABILITY AND REACTIVITY

Reactivity : Not classified as a reactivity hazard.

Chemical stability : Stable under normal conditions.

Possibility of hazardous reac- tions

: Can react with strong oxidizing agents.

Conditions to avoid : None known.

Incompatible materials : Oxidizing agents Hazardous decomposition

products

: No hazardous decomposition products are known.

SECTION 11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure Inhalation

Skin contact Ingestion Eye contact Acute toxicity

Not classified based on available information.

Components:

Sodium [1α(Z),2β(1E,3R*),3α,5α]-(+/-)-7-[2-[4-(3-chlorophenoxy)-3-hydroxybut-1-enyl]-3,5- dihydroxycyclopentyl]hept-5-enoate:

Acute oral toxicity : Acute toxicity estimate: 500 mg/kg Method: Expert judgment

Skin corrosion/irritation

Components:

Result : Skin irritation

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Serious eye damage/eye irritation

Components:

Result : Irritation to eyes, reversing within 21 days

Respiratory or skin sensitization Skin sensitization

Respiratory sensitization

Germ cell mutagenicity

Components:

Genotoxicity in vitro : Test Type: Bacterial reverse mutation assay (AMES) Result: positive

Test Type: In vitro mammalian cell gene mutation test

Result: positive

Test Type: Chromosome aberration test in vitro

Result: positive

Genotoxicity in vivo : Test Type: Mutagenicity (in vivo mammalian bone-marrow cytogenetic test, chromosomal analysis)

Species: Mouse

Application Route: Intraperitoneal injection Result: negative

Germ cell mutagenicity - Assessment

: Weight of evidence does not support classification as a germ cell mutagen.

Carcinogenicity

IARC No ingredient of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.

OSHA No component of this product present at levels greater than or equal to 0.1% is on OSHA’s list of regulated carcinogens.

NTP No ingredient of this product present at levels greater than or equal to 0.1% is identified as a known or anticipated carcinogen by NTP.

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Reproductive toxicity

Components:

Effects on fertility : Test Type: Three-generation reproduction toxicity study Species: Rat

Application Route: Ingestion Result: negative

Species: Rat

Application Route: Ingestion Result: positive

Effects on fetal development : Test Type: Three-generation reproduction toxicity study Species: Rat

Application Route: Ingestion Result: positive

Reproductive toxicity - As- sessment

: Some evidence of adverse effects on sexual function and fertility, and/or on development, based on animal experiments.

STOT-single exposure

Components:

Assessment : May cause respiratory irritation.

STOT-repeated exposure

Components:

Assessment : No significant health effects observed in animals at concentra- tions of 100 mg/kg bw or less.

Repeated dose toxicity Components:

Species : Rat

NOAEL : 0.050 mg/kg

Application Route : Ingestion

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Aspiration toxicity

SECTION 12. ECOLOGICAL INFORMATION

Ecotoxicity No data available

Persistence and degradability No data available

Bioaccumulative potential No data available

Mobility in soil No data available Other adverse effects No data available

SECTION 13. DISPOSAL CONSIDERATIONS

Disposal methods

Waste from residues : Dispose of in accordance with local regulations.

Contaminated packaging : Empty containers should be taken to an approved waste handling site for recycling or disposal.

If not otherwise specified: Dispose of as unused product.

SECTION 14. TRANSPORT INFORMATION

International Regulations UNRTDG

Not regulated as a dangerous good IATA-DGR

Not regulated as a dangerous good IMDG-Code

Not regulated as a dangerous good

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied.

Domestic regulation 49 CFR

Not regulated as a dangerous good SECTION 15. REGULATORY INFORMATION

EPCRA - Emergency Planning and Community Right-to-Know CERCLA Reportable Quantity

Components CAS-No. Component RQ

(lbs)

Calculated product RQ (lbs)

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4-Chloro-3-methylphenol 59-50-7 5000 *

*: Calculated RQ exceeds reasonably attainable upper limit.

SARA 304 Extremely Hazardous Substances Reportable Quantity This material does not contain any components with a section 304 EHS RQ.

SARA 302 Extremely Hazardous Substances Threshold Planning Quantity This material does not contain any components with a section 302 EHS TPQ.

SARA 311/312 Hazards : No SARA Hazards

SARA 313 : This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.

US State Regulations

Pennsylvania Right To Know

Water 7732-18-5

4-Chloro-3-methylphenol 59-50-7

The ingredients of this product are reported in the following inventories:

AICS : not determined

DSL : not determined

IECSC : not determined

SECTION 16. OTHER INFORMATION

Further information

NFPA 704: HMIS® IV:

HMIS® ratings are based on a 0-4 rating scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents a chronic hazard, while the "/" represents the absence of a chronic hazard.

Full text of other abbreviations Flammability

Health Instability

0 1

0

Special hazard.

FLAMMABILITY

1

PHYSICAL HAZARD HEALTH

0 / 0

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AICS - Australian Inventory of Chemical Substances; ASTM - American Society for the Testing of Materials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation, and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Sub- stances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Haz- ardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;

ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized Sys- tem; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organiza- tion; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemi- cals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Pre- vention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Oth- erwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quanti- tative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;

REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concern- ing the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amend- ments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used to compile the Material Safety Data Sheet

: Internal technical data, data from raw material SDSs, OECD eChem Portal search results and European Chemicals Agen- cy, http://echa.europa.eu/

Revision Date : 10/15/2018

Items where changes have been made to the previous version are highlighted in the body of this document by two vertical lines.

The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and shall not be considered a warranty or quality specification of any type. The information provided relates only to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text. Material users should review the information and recommendations in the specific context of their intended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.

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